Article
A novel scheme for the reporting of adverse drug reactions
A Clarksona, E Inglebya, I Choonaraa, P Bryanb, P Arlettb
a Academic Division of
Child Health (University of Nottingham), Derbyshire Children's
Hospital, Uttoxeter Road, Derby DE22 3NE, UK, b Medicines
Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ,
UK
Correspondence to: Prof. Choonara imti.choonara{at}nottingham.ac.uk
Accepted 30 November
2000
BACKGROUND
The safety of medicines
used in children is of considerable public interest, yet available data
to monitor the safety of medicines in children is limited.
AIMSTo raise awareness and
stimulate reporting of adverse drug reactions (ADRs) in children in the
Trent region.
METHODSA pilot Paediatric Regional
Monitoring Centre (PRMC) has been established in the Trent region. The
scheme operates as an extension of the UK's spontaneous reporting
scheme, the Yellow Card Scheme run by the Medicines Control Agency and
the Committee on Safety of Medicines. Proactive interventions including
a monthly reminder letter and presentations to staff in the identified
hospitals have been made.
RESULTSDuring the first year of
the PRMC, 95 reports were received from the Trent region compared to 40 for the previous year. Twenty four of these reports were for medicines
used "off label". The 95 reports involved 105 drugs and 171 suspected ADRs. Twenty six of the ADRs (15%) were considered medically significant.
CONCLUSIONSThe number of ADR
reports from the Trent region has increased considerably in the first
year of the scheme. The results show that intensive education and
promotion of ADR reporting can result in a major increase in reporting.
This initiative will increase our knowledge about the safety of
medicines used to treat children and so help protect public health.
Keywords: adverse drug reactions; surveillance; Yellow Card Scheme
© 2001 by Archives of Disease in Childhood
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